To evaluate the change in volumetric BMD (VBMD) at the radius, tibia, hips and lumbar spine

Change in Vitamin D levels [ Time Frame: 12 months ]

To evaluate the change in vitamin D levels with supplementation

Change in Biochemical markers [ Time Frame: 12 months ]

To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of bone turnover and markers of inflammation.

Original Secondary Outcome Measures ICMJE (submitted: June 16, 2011)

Areal Change in Bone Mineral Density (aBMD) [ Time Frame: 12 months ]

To evaluate the change in areal BMD (aBMD) at the total hip (TH), femoral neck (FN), and distal radius (DR);

Volumetric Bone Mineral Density (vBMD) [ Time Frame: 12 months ]

To evaluate the change in volumetric BMD (VBMD) at the radius, tibia, hips and lumbar spine

Change in Vitamin D levels [ Time Frame: 12 months ]

To evaluate the change in vitamin D levels with supplementation

Biochemical markers [ Time Frame: 12 months ]

To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of bone turnover and markers of inflammation.

Immune function [ Time Frame: 12 months ]

To evaluate the effect of vitamin D supplementation on biochemical markers of immune function

Muscle measures and frailty [ Time Frame: 12 months ]

To evaluate the effect of vitamin D supplementation on muscle strength.

Biochemical Markers [ Time Frame: 12 months ]

To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of inflammation.

Muscle measures and frailty [ Time Frame: 12 months ]

To evaluate the effect of vitamin D supplementation on functional muscle performance.

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Vitamin D HIV Study on Postmenopausal Women

Official Title ICMJE

The Effect of Vitamin D Repletion on Postmenopausal Women With HIV

Brief Summary

The purpose of this study is to determine the effects of vitamin D on measures of bone health and immune function in HIV infected postmenopausal women. The investigators prior research with this population revealed that low vitamin D levels are very common. Prior research with this population also revealed that Vitamin D is necessary for the body to absorb calcium and is important for the health of the bones. When vitamin D levels are low, there are increased risks of bone loss, muscle weakness, falls and fractures. Low levels of vitamin D have also been associated with impaired immune function. This study will help us learn whether two different doses of vitamin D will improve bone health and immune function.

Detailed Description

The purpose of this study is to determine the effects of vitamin D repletion on rates of bone loss and indices of immune function in HIV+ postmenopausal women. Lower baseline serum Vitamin D levels, as assessed by measuring serum 25-hydroxyvitamin D (25-OHD) were associated with a trend toward more bone loss. In addition, the investigators found that despite providing supplements that contained approximately 600 IU vitamin D, serum 25-OHD did not increase during the first year. Provision of adequate calcium and vitamin D is the cornerstone of effective prevention and therapy of osteoporosis. HIV-infected patients may be at increased risk of having vitamin D deficiency because they take several medications that may interfere with vitamin D action. Therefore, the investigators will recruit 100 HIV infected postmenopausal women for this study who are on a stable antiretroviral therapy (ART) regimen and randomize them to receive 1000 or 3000 IU of vitamin D daily. The subjects will be followed closely for one year to monitor compliance and changes in bone health and immune function.

HIV+ African American and Latina postmenopausal women, aged 40-70, who meet the standard definition of menopause:

If 50 years old or older then amenorrhea for > 1year. If age 40 to 49 then amenorrhea for over a year and and Follicle-Stimulating Hormone (FSH) level of equal to or greater than 20 mIU/ml; as some amenorrheic chronically ill women may have hypothalamic dysfunction and low FSH values, if FSH is 10 to 19, and the serum estradiol level is consistent with menopause less than or equal to 30pg/ml, she will be determined to be postmenopausal.

On stable antiretroviral therapy (ART) for >2 years

Undetectable HIV RNA (viral load) at least 2 times over the past year (RNA <400)

Current use of glucocorticoids, anticonvulsants, anticoagulants, diuretics, methotrexate;

Current or past use of drug therapies for osteoporosis (raloxifene, bisphosphonates, calcitonin, PTH). Women on estrogen are excluded. Past estrogen use is permitted if discontinued >1 year before enrollment.

If there is a history of a low trauma fracture, a T score < -3 or a prevalent vertebral fracture on Instant Vertebral Assessment™ (IVA), subjects will be referred for osteoporosis treatment as appropriate.